The New England Journal of Medicine (NEJM) has published positive results from the cutaneous lupus erythematosus (CLE) portion of the two-part phase 2 LILAC study, assessing Biogen’s litifilimab – known as BIIB059 – an investigational drug developed to treat lupus.
Litifilimab – a humanised IgG1 monoclonal antibody (mAb) targeting blood dendritic cell antigen 2 (BDCA2) – met its primary endpoint by showing superior efficacy to placebo in reducing skin disease activity.
BDCA2 is a receptor that is exclusively expressed on a subset of human immune cells known as Plasmacytoid Dendritic Cells (pDCs). It has been proven to reduce inflammatory production from pDCs, including type-I IFN (IFN-I), as well as other cytokines and chemokines. Such inflammatory mediators are believed to be key in the pathogenesis of systemic and cutaneous lupus.
The company has pushed litifilimab to the next phase in late-stage development and is enrolling participants with systemic lupus erythematosus (SLE) into the phase 3 TOPAZ-1 and TOPAZ-2 studies. Biogen plans to begin a pivotal study in CLE later this year.
Read more: https://www.pmlive.com/pharma_news/positive_results_for_biogens_lupus_drug_published_in_nejm_1452884